Are existing standard methods suitable for the evaluation of nanomedicines: some case studies

Abstract

The use of nanotechnology in medical products has been demonstrated at laboratory scale, and many resulting nanomedicines are in the translational phase toward clinical applications, with global market trends indicating strong growth of the sector in the coming years. The translation of nanomedicines toward the clinic and subsequent commercialization may require the development of new or adaptation of existing standards to ensure the quality, safety and efficacy of such products. This work addresses some identified needs, and illustrates the shortcomings of currently used standardized methods when applied to medical-nanoparticles to assess particle size, drug loading, drug release and in vitro safety. Alternative physicochemical, and in vitro toxicology methods, with the potential to qualify as future standards supporting the evaluation of nanomedicine are provided.

Characterisation of particles in solution – a perspective on light scattering and comparative technologies

“…This can be critical for high-resolution analysis or when adopting highly resolving instruments, where the results can be found questionable. However, by adopting appropriate techniques, reference materials and protocols, then one can obtain very valuable information concerning the particle surface, if the measurements are done correctly, thereby aiding in the characterisation of functionalised materials, for example [12,13]. …”

“…Single-particle inductively coupled plasma mass spectrometry can also be used to calculate particle sizes and concentrations, but is generally suited only for metal-containing NPs. To counteract this, analytical centrifugation can be utilised to determine PSDs and concentrations [12,33]. This technique does not require the use of a calibrator as it is a first-principles-based method that separates and characterises materials based on their density.…”

“…This technique does not require the use of a calibrator as it is a first-principles-based method that separates and characterises materials based on their density. As such it is not substance specific, and can be used to characterise enumerate materials [12]. Another promising technique for measuring particle concentration is laser-induced breakdown detection (LIBD).…”

Safety Issue of Changed Nanotoxicity of Zinc Oxide Nanoparticles in the Multicomponent System

“…Nanomaterials (NMs) are increasingly applied in the medicine, energy storage, catalysis, biosensors, cosmetics, and food fields . Due to more and more direct contact with nanoparticles (NPs), their safety has been a cause for the public concern for a number of years . Many studies have focused on the safety of NMs.…”

“…DOI: 10.1002/ppsc.201900214 nanoparticles (NPs), their safety has been a cause for the public concern for a number of years. [3][4][5][6] Many studies have focused on the safety of NMs. The earliest research work on the safety of NMs was that scientists at the University of Oxford and the University of Montreal in 1997 discovered that titanium dioxide NPs (TiO 2 NPs) and zinc oxide nanoparticles (ZnO NPs) in sunscreens destroyed DNA in skin cells.…”